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Entecavir

These highlights do not include all the information needed to use entecavir tablets safely and effectively. See full prescribing information for entecavir tablets. ENTECAVIR tablets, for oral use. Initial U.S. Approval: 2005

Approved
Approval ID

01ec50a1-6c6c-46f0-8c74-73542b0a59c3

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 24, 2019

Manufacturers
FDA

Camber Pharmaceuticals, Inc.

DUNS: 826774775

Products 2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Entecavir

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code31722-833
Application NumberANDA205740
Product Classification
M
Marketing Category
C73584
G
Generic Name
Entecavir
Product Specifications
Route of AdministrationORAL
Effective DateDecember 24, 2019
FDA Product Classification

INGREDIENTS (10)

ENTECAVIR ANHYDROUSActive
Quantity: 0.5 mg in 1 1
Code: NNU2O4609D
Classification: ACTIB
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
THIAMINE MONONITRATEInactive
Code: 8K0I04919X
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT

Entecavir

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code31722-834
Application NumberANDA205740
Product Classification
M
Marketing Category
C73584
G
Generic Name
Entecavir
Product Specifications
Route of AdministrationORAL
Effective DateDecember 24, 2019
FDA Product Classification

INGREDIENTS (10)

CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
ENTECAVIR ANHYDROUSActive
Quantity: 1 mg in 1 1
Code: NNU2O4609D
Classification: ACTIB
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
THIAMINE MONONITRATEInactive
Code: 8K0I04919X
Classification: IACT

Drug Labeling Information

BOXED WARNING SECTION

LOINC: 34066-1Updated: 12/24/2019

BOXED WARNING

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